Clinical trial · Interventional

Weekly Gemcitabine, Epirubicin, and Docetaxel in Locally Advanced or Inflammatory Breast Cancer

Phase II Trial of Induction Chemotherapy With Weekly Gemcitabine, Epirubicin, Docetaxel as Primary Treatment of Locally Advanced or Inflammatory Breast Cancer Patients

NCT00193050CI-TRIAL-00054672completedPhase 2Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

Treatment strategies that include induction chemotherapy have several potential advantages: early initiation of systemic chemotherapy, in vivo assessment of response, and down-staging of both the primary tumor and regional lymphatic metastases, making breast conservation an option for many. The aim of the present study is to determine the efficacy and toxicity of induction combination chemotherapy with the triplet, gemcitabine, epirubicin, and docetaxel, in patients with locally advanced or inflammatory breast cancer. Clearly, it is in the upfront treatment as well as in the adjuvant treatment of breast cancer, that effective new agents and combination of agents are likely to have the greatest potential impact.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Breast Cancer	Malignant Breast Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (3)

Intervention	Type	Mapped drug	Match
Docetaxel	Drug	Docetaxel	ALIAS
Epirubicin	Drug	Epirubicin	ALIAS
Gemcitabine	Drug	Gemcitabine	ALIAS

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Intervention
description
In the neoadjuvant setting, patients were administered gemcitabine (800 mg/m2 IV days 1 and 8), epirubicin (75 mg/m2 IV day 1), and docetaxel (30 mg/m2 IV days 1 and 8)repeated every 21 days for 4 cycles Patients then had either mastectomy or breast conservation surgery and pathologic treatment responses were assessed. After surgery, 4 cycles of adjuvant gemcitabine (1000 mg/m2 IV days 1 and 8) and docetaxel (35 mg/m2 IV days 1 and 8) were administered at 21 day intervals. After completion of chemotherapy, local regional radiation therapy and/or anti-estrogen therapy was administered per standard guidelines.
interventionNames
1. Drug: Gemcitabine
2. Drug: Epirubicin
3. Drug: Docetaxel

Primary outcomes (1)

measure
Pathologic Complete Response (pCR)
timeFrame
18 Months
description
For the purpose of this study, a Pathologic complete response (pCR) was defined as no evidence of residual invasive tumor in the breast (pT0). Residual ductal or lobular carcinoma in situ was not considered in pCR assessments. Percentage of participants who experienced pCR is reported.

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

To be included in this study, you must meet the following criteria:

* Adenocarcinoma of the breast confirmed by biopsy
* Female Patients \>18 years of age
* Normal cardiac function
* Ability to perform activities of daily living with minimal assistance
* Chemotherapy naïve or have received prior chemotherapy \> 5 years ago
* Adequate bone marrow, liver and kidney function
* Be informed of the investigational nature of this study
* Sign an informed consent form
* Sentinel lymph node and/or axillary dissection prior to enrollment

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

* Life expectancy of \< than 6 months
* History of significant heart disease
* Prior chemotherapy or hormonal therapy
* Concurrent Trastuzumab therapy
* History of significant psychiatric disorders
* History of active uncontrolled infection

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

References

Publications (1)

RESULTYardley DA, Peacock NW, Dickson NR, White MB, Vazquez ER, Foust JT, Grapski R, Hendricks LK, Scott WL, Hainsworth JD. A phase II trial of neoadjuvant gemcitabine, epirubicin, and docetaxel as primary treatment of patients with locally advanced or inflammatory breast cancer. Clin Breast Cancer. 2010 Jun;10(3):217-23. doi: 10.3816/CBC.2010.n.029. PMID 20497920